Equipment Qualification and Validation of Processes

Location: Raleigh-Durham, NC, USA       Duration: 2 days

Date: September 13 - 14, 2018 from 830AM-430PM edt

Presenter: Joy McElroy

The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls — you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

Areas Covered:

  • Regulatory Requirements and Expectations for Equipment Qualification

    • Europe

    • FDA

      • Global harmonization and expectations

      • Management of Documents, Documents Required

    • Validation policy

      • Validation Master Plan (VMP)

      • Documents equipment qualification

      • SOPs

      • Responsibilities

      • Validation team

    • Presumption for qualification/validation

  • General Aspects of Qualification

    • Qualification phases, DQ, IQ, OQ, PQ

    • Qualification of existing systems and equipment

    • Requalification/validation

  • Performance Qualification and Process Validation

    • SOPs

    • Writing a qualification protocol, content

    • Executing a qualification

    • Tests and data

    • Documents

    • Writing a qualification final report

Key Learning Objectives

  • Understand what the global expectations are for equipment qualification and validation

  • Understand the documents required for equipment qualification and process validation and how to manage documents appropriately

  • Understand and know how to write and maintain a Validation Master Plan

  • Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation

  • Qualify already existing systems and requalification

  • Be able to collect data, conduct tests, and obtain all necessary documents

  • Understand the different types of validation

  • Understand performance validation

  • Know the guidelines on validating analytical methods and processes

  • Support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control

  • Understand and know the principles of auditing the equipment qualification and validation

  • Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier

  • To investigate true root causes of problems and to evaluate and prioritize solutions

  • Problem solving methods to help you asses which is best for your situation

  • Develop successful implementation plans

  • Perform risk assessments effectively

Who will Benefit?

  • Senior quality managers

  • Quality professionals

  • Regulatory professionals

  • Compliance professionals

  • Production supervisors

  • Validation engineers

  • Manufacturing engineers

  • Production engineers

  • Design engineers

  • Process owners

  • Quality engineers

 

            1-800-549-0815                 ext. 1

           
 

 

  • c-facebook
  • c-twitter
  • c-linkedin

© 2017 Maynard Consulting​ Company